FDA Adverse Event
Injury
Summary report: N
SPINBRUSH
MDR report key: 2010568
·
Received March 1, 2011
Report
- Report Number
- 2280705-2011-00008
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- January 31, 2011
- Report Date
- March 1, 2011
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPONENTS ARE MFG AT THE FOLLOWING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, WE ARE UNABLE TO DETERMINED WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MADE. (B)(4). CONSUMER HAS NOT RETURNED PRODUCT TO DATE, THEREFORE, IT COULD NOT BE EVALUATED AND NO CONCLUSIONS COULD BE DRAWN.
Description of Event or Problem · 1
CONSUMER REPORTED THE BOTTOM PART OF THE BRUSH CAUGHT ON ONE OF HIS FRONT TEETH WHILE HE WAS BRUSHING. IT KNOCKED OFF A RICE GRAIN BIT OF TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH | TOOTHBRUSH, POWERED SECTION 872.6865 (JEQ) | JEQ | CHURCH & DWIGHT CO., INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |